TANTUM VERDE GOLA NEB 15ML0,25

TANTUM VERDE GOLA 250 MG/100 ML

active ingredients

100 ml contain: active ingredient: flurbiprofene 250 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Collumination : glycerol, ethanol (96%), crystallized liquid sorbitol, castor oil 40 hydrogenated polyxyethylene, sodium saccharin, bicarbonate potassium, benzoate sodium, mint aroma, blue patent V (E 131), purified water. Oral Mucosa Spray, Solution: glycerol, ethanol (96 percent), crystallized liquid sorbitol, sodium saccharin, bicarbonate potassium, benzoate sodium, mint aroma, polysorbate 20, purified water.

Therapeutic indications

Syntomatic treatment of irritative-inflammatory states, also associated with pain of the oropharyngeal cable (e.g. pharyngitis).

Contraindications

Tantum Green Gola is contraindicated in patients with known hypersensitivity (asthma, hives or allergic type) to flurbiprofen or any of the excipients listed in paragraph 6.1 and to aspirin or other NSAIDs. Third quarter of pregnancy. Do not use in patients who are suffering from peptic ulcer or have been affected in the past.

Population

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4 Special warnings and precautions for use). Collutory: The recommended dose is 2-3 gargarisms per day with 10 ml of collutory. Pour in the dosing cup 10 ml of Tantum Verde Gola collutorio to be used in pure form, such as gargarism. Oral mucosal spray, solution: The recommended dose is 2 sprays 3 times a day directly addressed to the affected part. Each spray dispenses 0.2 ml of solution equivalent to 0.5 mg of active ingredient. Use the medication at any time of the day. Be careful not to exceed the doses indicated.

Conservation

This medicine does not require any special condition of conservation.

Warnings

In recommended doses, the occasional swallowing of Tantum Verde Gola does not involve any harm to the patient as such doses are largely lower than those commonly used in treatment with flurbiprofen via systemic. Tantum Green Gola must be used with caution by patients with non-allergic asthma, in fact cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi. The use of the product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. In such cases it is necessary to stop the treatment and to establish, if necessary, suitable therapy. Do not use for protracted treatments.

Interactions

There are no known interactions with other drugs or other types.

Effects

They were reported, in particular after administration of formulations for systemic use, the following side effects, reported according to the systemic and organic classification MedDRA. The following values scales have been used: very common (≥1/10); common (≥1/100, Classification for systems and organs according to MedDRA Frequency not known (frequency cannot be defined on the basis of available data) Emolinfopoietic system pathologies Trombocytopenia, aplastic anemia, agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders Depression, confusion, hallucination Diseases of the nervous system Capogiro, hemorrhage and cerebrovascular accidents, optic neuritis, migraine, paresthesia, drowsiness. Pathologies of the eye Visual disturbances Ear and labyrinth pathologies Tinnitus, vertigo Respiratory, chest and mediastinic pathologies Asthma, bronchospasmo, dispnea Gastrointestinal diseases Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, gastrointestinal hemorrhage, colitis and Crohn's disease, gastritis, peptic ulcer, perforation and gastric ulcer with hemorrhaging. Pathologies of skin and subcutaneous tissue Bollose conditions (included, Stevens Johnson syndrome, epidermal toxic necrolysis, multiform erythema), skin pathologies including skin rash, itching, hive, porpora Kidney and urinary pathologies Renal insufficiency, nephrotoxicity in various forms including interstitial nephritis and nephrosic syndrome Systemic pathologies and conditions for administration Fastidium, fatigue Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

In view of the reduced content of active ingredient and its local use it is unlikely that overdose situations may occur. Synonyms Overdose symptoms may include nausea, vomiting and irritation of the gastrointestinal tract. Treatment In case of such eventuality, appropriate treatments should be adopted; the gastric lavender is indicated and, if necessary, the correction of any imbalances of the serum electrolytes. There are no specific antidotes of flurbiprofen.

During the first and second trimester of pregnancy, Tantum Green Gola should not be administered if not in strictly necessary cases. Tantum Green Gola should not be used by the third trimester of pregnancy. Flurbiprofene is not recommended in nursing mothers.

Source: Farmadati